The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

1. Present By- Manpreet Ghai
Tanaya Palit
M.Pharm (Pharmaceutics) 2nd sem

2. CONTENT
 Quality
 quality by design
 How can we achieve Quality by Design ?
 What is ICH Q8 ?
 Objective of ICH guidelines
 Pharmaceutical Development Q8
 Examples of QbD Approaches
 Regulatory Agency and Industry views on QbD
 Conclusion
 Reference

3.  WHAT IS QUALITY ?

4. QUALITY BY DESIGN

5. Means
Designing and
developing
formulations and
manufacturing
process to ensure a
predefined quality

6. HOW CAN WE ACHIEVE QUALITY BY
DESIGN ?

7. WHAT IS ICH Q8 ?
 Guidelines for the descriptions what is in P2
 Describe the minimal standard for P2
 Opens door to get closer to the
“Described State”
- Science based
- Includes risk management
- Continuous improvement
- Real Times Release

8. OBJECTIVE OF ICH GUIDELINES
 to review and study ICH guidelines
Q8
 to understand the concept of ICH
guidelines Q8
 to know the importance and study the
benefits of ICH guidelines Q8

9. PHARMACEUTICAL DEVELOPMENT Q8
Describes science and risk-based
approaches for pharmaceutical
product and manufacturing process
development.
Introduced concepts of design space
and flexible regulatory approaches.
 introduced concept of Quality by
Design (QbD) and provided examples
of QbD development approaches and
design space.

10. EXAMPLES OF QBD APPROACHES
• Quality Target Product Profile
(QTPP)
• Determine ‘potential’ critical quality
attributes (CQAs)
• Link raw material attributes and
process parameters CQAs and
perform risk assessment.
• Development a design space
(Optional and no required).
• Design and implement a control
strategy.
• Manage product lifecycle.

11. REGULATORY AGENCY AND INDUSTRY VIEWS ON
QBD
Industry Regulatory Agency
Integrate across business
units(e.g. R&D,
manufacturing quality)
Integrate review
inspection and
compliance
Integration across
disciplines (e.g.
chemist,engineer,statistici
ans)
Incorporate
multidisciplinary CMC
review(e.g.
chemist,engineer,statistici
ans)
Incorporate quality system
to manage the new
approach
Implement Quality
Management system

12. CONCLUSION
Why we use quality by Design ?
 Provides a proactive approaches to product
development potential to reduce queries and review
time to quickly get to the root cause and resolution
of any deviations.
 Allows for continues improvements in product and
manufacturing.
 Allows for better understanding how APIs and
excipients affects manufacturing.
 increase manufacturing efficiency , reduce cost
and waste

13. REFERENCE
 Computer-aided applications in pharmaceutical
technology, published by Woodhead publishing
Limited,2013,Quality-by-design in pharmaceutical
development, page no. 1-15
 World Journal of Pharmaceutical Research ,volume
2, Issue 5,1409-1422, ISSN 2277-7105,Quality by
Design-Novelty In
Pharmaceuticals,Shajeeya,Amren.SK*,ViswanathA.
Srinivasa Babu P.